Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial

This study has been completed.
Sponsor:
Collaborator:
RTI International
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00630188
First received: February 28, 2008
Last updated: March 5, 2008
Last verified: February 2008
  Purpose

The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.


Condition Intervention
Prostatic Neoplasms
Other: You Decide
Other: Reducing Your Risks in the Crash

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Men's understanding that prostate cancer screening requires a decision [ Time Frame: baseline, post intervention, post clinical visit ] [ Designated as safety issue: No ]
  • Men's knowledge about prostate cancer and prostate cancer screening [ Time Frame: baseline, post intervention, post clinical visit ] [ Designated as safety issue: No ]
  • Men's participation in the decision about prostate cancer screening with their clinician at their preferred level [ Time Frame: baseline, post intervention, post clinical visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The presence of a shared decision [ Time Frame: post clinical visit ] [ Designated as safety issue: No ]
  • men's intent to be screened for prostate cancer [ Time Frame: post clinical visit ] [ Designated as safety issue: No ]
  • Self reported screening [ Time Frame: post visit ] [ Designated as safety issue: No ]
  • Actual screening by chart review [ Time Frame: 9 month follow-up ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: March 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with physician

For Physicians: a one-time educational session on prostate cancer and the value of shared decision making

Other: You Decide

For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with clinician

For Physicians: a one-time educational session on prostate cancer and the value of shared decision making

Active Comparator: 2
Highway Safety video
Other: Reducing Your Risks in the Crash
Publicly available video on highway safety and reducing individual risks in a crash

Detailed Description:

Background: Professional societies recommend shared decision making for prostate cancer screening, however, most effort has been directed at informed rather than shared decision making. In this study, we plan to test the effects of a shared decision making intervention on key components of shared decision making. We secondarily plan to test its effects on the presence of a shared decision, men's intention to be screened, and actual screening rates.

Methods: We plan to conduct two separate randomized controlled trials of shared decision making interventions, one in which the intervention focuses on prostate cancer screening only and one in which the intervention focuses on prostate cancer screening in the context of other men's health issues. Each trial will use the same attention control and identical implementation and measurement strategies to allow combination of data if no differences exist in the effect of the interventions. Trials will include a convenience sample of men with no prior history of prostate cancer who present to their primary care physician for routine care. Men will be randomly assigned to a shared decision making intervention (including a video and coaching session for patients and an education session for providers) or a control group, in which men will receive a video on highway safety. Data on key components of shared decision making and intent for screening will be measured at baseline, after the intervention, and after men's visit with their provider. Additionally, medical charts will be reviewed 9 months later to assess for actual screening.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 40-80 years
  • Their physician agreed to participate in the study
  • Seen in practice for at least one year

Exclusion Criteria:

  • Prior history of prostate cancer
  • Presenting for acute medical visit
  • Non-skin cancer
  • Lung disease requiring oxygen
  • Renal failure requiring dialysis
  • Intensive care visit in last 6 months
  • Need assistance with activities of daily living
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630188

Locations
United States, North Carolina
University of North Carolina at Chapel Hill General Medicine Clinic
Chapel Hill, North Carolina, United States, 27599
Chapel Hill North General Internal Medicine Practice
Chapel Hill, North Carolina, United States, 27516
Triad Internal Medicine
Greensboro, North Carolina, United States, 27405
Moses Cone Internal Medicine Practice
Greensboro, North Carolina, United States, 27401
Sponsors and Collaborators
University of North Carolina
RTI International
Investigators
Principal Investigator: Russ Harris, MD, MPH University of North Carolina, Chapel Hill
Principal Investigator: Lauren McCormack, PhD, MSPH RTI International
Principal Investigator: David Driscoll, PhD, MSPH RTI International
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Russell P Harris, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00630188     History of Changes
Other Study ID Numbers: TS-0845
Study First Received: February 28, 2008
Last Updated: March 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
prostate cancer screening
shared decision making
prostate-specific antigen
decision making
physician-patient relations

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014